Recalls / Class II
Class IID-1318-2022
Product
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
- Brand name
- Debrox
- Generic name
- Carbamide Peroxide
- Active ingredient
- Carbamide Peroxide
- Route
- Auricular (otic)
- NDC
- 63029-321
- FDA application
- M014
- Affected lot / code info
- Part# 04203710478
Why it was recalled
CGMP Deviations: products were stored outside the drug label specifications.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Medtech Products Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 131 boxes
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2024-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1318-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.